Reimbursement for Subject Injuries in Clinical Trials How to Avoid an ‘Adverse Event’ to Your Business

Many sponsors and providers are either not aware of, or do not fully appreciate, the potential consequences of reimbursement for patient injury clauses in clinical trial agreements.

In addition to potentially paying more than expected, unsuspecting sponsors may face an obligation to file reports with the Centers for Medicare & Medicaid Services, incur significant fines for failure to do so and run afoul of HIPAA obligations.

Providers must be concerned when complying with Medicare regulations, balancing ethical considerations with institutional policies.

And it couldn’t be more convenient. Simply make sure you're in front of a screen at the appointed time, whether you’re at the office or telecommuting from your in-home office.

Sponsors and providers need to be prepared when something goes wrong, and your contract must cover all the right steps to ensure you are staying within regulations.

If you’re involved in clinical trial agreement negotiations, Reimbursement for Subject Injuries in Clinical Trials: How to Avoid an ‘Adverse Event’ to Your Business is one encore presentation you simply can’t afford to skip. You pay a single low registration fee per facility, regardless of how many people participate. So spread the word.

David A. Charapp is partner at Duane Morris LLP and co-chair of the firm's Technology Transactions and Licensing Practice Group and represents life sciences and technology companies with their critical partnering, licensing and financing transactions, as well as operational agreements such as those for manufacturing and supply, distribution and clinical and preclinical research. Mr. Charapp has substantial experience as an in-house attorney, having been associate general counsel for Santarus, Inc., a specialty pharmaceutical company, and Kosan Biosciences Inc., a biotechnology company acquired by Bristol-Myers Squibb. Mr. Charapp earned his law degree from Boston College Law School (J.D., magna cum laude, 1997), where he was elected to the Order of the Coif.

Erin M. Duffy is an associate at Duane Morris LLP where she concentrates her practice on corporate healthcare regulatory matters. She advises clients on a wide range of issues, including fraud and abuse, self-referral, Medicare and Medicaid reimbursement, corporate practice of medicine and fee-splitting prohibitions, tax-exempt status, and certificate of need and licensure issues. She is also experienced in handling healthcare information technology matters, including mobile (mHealth) and electronic health records. Ms. Duffy is a graduate of Temple University Beasley School of Law.

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